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Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

NCT05230810 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-16

No results posted yet for this study

Summary

Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.

Conditions

Interventions

DRUG

Alpelisib

Orally twice a day

DRUG

Tucatinib

Orally once a day

DRUG

Fulvestrant

500 mg intramuscularly into the buttocks slowly \*Fulvestrant will be administered only in patients with HR+/HER2+ metastatic breast cancer

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Seagen Inc.

    collaborator INDUSTRY

  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Elena Shagisultanova, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-25
Primary Completion
2026-03-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230810 on ClinicalTrials.gov